Rabies Virus Vaccine ELISA Kit

Name: Rabies Virus Vaccine ELISA Kit
SKU: DEIA-RV2310-15
Rating: 5 (1 reviews)

Regulatory status: For research use only, not for use in diagnostic procedures.

COA

SDS

Datasheet

Summary

Sample

vaccines formulated in Aluminum hydroxide or Alum gel

Species Reactivity

N/A

Detection Method

dELISA

Intended Use

The ELISA is for the measurement of Rabies Virus Vaccine formulated in Alum For In Vitro Research Use Only (RUO).
The ELISA for Rabies Virus is the test to measure the active component of the vaccine in vaccines formulated in Aluminum hydroxide or Alum gel. It is a simple, rapid, and sensitive test and required no extraction or harsh dissociation of the antigens from the gel (Alum). This kit has been validated with IMRAB® (Merial) rabies vaccine for animals which contains the same virus strain used in the human vaccine.

Contents of Kit

1. Rabies Virus Std. A (0 U/ml), 0.65 ml
2. Rabies Virus Std. B (3 U/ml), 0.65 ml
3. Rabies Virus Std. C (11 U/ml), 0.65 ml
4. Rabies Virus Std. D (33 U/ml), 0.65 ml
5. Rabies Virus Std. E (100 U/ml), 0.65 ml
Note: All Stds are made in Alum suspension. Shake well and mix before use.
6. Sample Diluent, pink solution, 15 ml (mix the contents prior to use)
7. Anti-RBV-HRP Conjugate, 80 μl (100×)
8. HRP Conjugate Diluent, 10 ml (20×). diluent 1:20 with water
9. Low NSB Diluent (Green solution), 15 ml (mix the contents prior to use), Ready to use
10. Wash buffer (100×), 10 ml. dilute 1:100 with distilled water
11. HRP substrate, Solution, 12 ml
12. Stop solution, 12 ml
13. ELISA Strip Plate (8×12 or 96 wells)
14. Assay Tubes, 50
15. Otips, 50

Storage

The kit contents, if unopened, are stable at 2-8°C until the expiration date printed on the label. The whole kit stability is at least 6 months from the date of shipping under appropriate storage conditions.

Performance Characteristics

Detection limit- Based on replicate detemminations of the zero standard, the minimum Rabies vaccine concentration detectable using this assay is greater than a 1:500 dilution of the vaccine. The detection limit is defined as the value deviating by 2 SD from the zero standard.

Precision

Samples (n=5) were run on the same lot to determine in intra-assay variability. Samples (n=5) were run across multiple days on multiple lots to determine inter-assay variability.

General Description

A vaccine is a biological preparation that improves immunity to a particular disease. Some vaccines also contain chemicals called adjuvants to help stimulate the production of immunity against the vaccine active ingredients, making the vaccine more effective. Currently, the only adjuvants approved for human vaccine are aluminum containing compounds, including aluminum hydroxide, aluminum phosphate, and potassium aluminum sulfate or alum. Aluminium adjuvants have been used in tetanus, diphtheria, pertussis, polio, rabies, and hepatitis A and B vaccines.
To ensure vaccine quality, regulatory authorities require the manufacturer to measure vaccine content in the final product. World Health Organization (WHO) recommends that at least 80% of the vaccine be adsorbed to the gel. In particular, it is essential to determine the amount as well as the identity and integrity of the antigens bound to aluminum containing adjuvants following formulation. Aluminum-based gels are typically fibrous or beaded in suspension. The presence of aggregates, turbidity, flocculent gels or beads in solution prevents direct quantitation of protein content in formulations using protein assays such as Lowry, BCA, or Bradford protein assay, not to mention that these assays are all non-specific and low in sensitivity. Alum formulations also do not allow complete dissolution or extraction making it very difficult to know the identity of the vaccines or know the amount of the protein after their dispensing. There have been several incidents of mislabeling of anti-fertility vaccine with tetanus vaccines. Therefore, there is an urgent need for a test not only to identify but measure the vaccine contents.

Standard Curve

NOTE: This data is for demonstration purpose only. A complete standard curve must be run in every assay to determine sample values. The 0 U standard should not be used in calculation of the curve only to normalize standard and sample values. Each laboratory should determine their own normal reference values.